FDA Mulls New Policy on Off-Label Promotion

Neurosurgeon urges agency to loosen restrictions

Physicians and consumer advocates warned FDA not to loosen its restrictions on companies marketing off-label medical products, during a public hearing Wednesday. But, while pharmaceuticals companies stopped short of requesting looser regulations, a physician speaking for two neurosurgical societies did not.

The issue was debated during the first of a 2-day public hearing hosted by FDA to get feedback on how it should regulate off-label promotion of medical products.

"FDA is engaged in a comprehensive review of its regulations and policies governing firms' communications about unapproved uses of approved/cleared medical products, and the input from this meeting will inform FDA's policy development in this area," the agency said in announcing the hearing.

Previously the FDA had strict regulations prohibiting nearly all promotion of unapproved indications for approved drugs and devices. But federal courts in 2012 and 2015 ruled that "truthful and non-misleading speech" by manufacturers about their products is protected under the First Amendment, forcing the FDA to revise its policies.

The input FDA heard Wednesday mostly leaned against allowing firms to market off-label products. Leading the way at the end of the day were Sidney Wolfe, MD, and Michael Carome, MD, of the consumer group Public Citizen.

If manufacturers want to market an off-label product, "finish the (necessary) study and get it approved," Wolfe said. "Then you can advertise."

Wolfe cited evidence from two recent studies showing problems with off-label marketing. Noting a contradiction between one of the studies and the FDA's proposed guidance, he added: "FDA should be working to decrease off-label use. Otherwise FDA would be complicit in the promotion of more reckless prescribing."

Carome read from a prepared statement: "The primary purpose for drug and device company representatives to distribute scientific and medical information regarding unapproved uses undoubtedly is to promote those uses to physicians and other healthcare providers and thereby increase prescribing of the companies' products. For the FDA or anyone else to suggest otherwise defies common sense. Such legalized off-label promotion -- even under the safe-harbor conditions specified in FDA guidance -- threatens the U.S. regulatory process for ensuring that prescription drugs and medical devices are safe and effective for their intended uses."

Robert Weissman, Public Citizen's president, then cautioned FDA that allowing off-label marketing would hark back to the public health "disasters" that led to FDA's existence in the first place.

Physicians "consider the source of all our information," said Welch. "We have available to us a number of scientific evaluations ... We do ask (FDA that) we have the ability to receive as much information as possible, so we can interpret the information independently."

Welch encouraged physicians to report failed products to FDA, which he said the agency allows, and to "use products we believe provide the best opportunity for patients to improve, even if we use them off label."

"The stigmata of off-label use can confuse healthcare professionals," he added. "We urge FDA to consider a more expedited process."

Before these public health advocates spoke, representatives with pharmaceutical and diagnostic companies addressed their problems with FDA's current regulations concerning communications of approved products. The companies cannot make sense of these rules, they said.

"We're looking for uniformity and clarity in the regulatory process, to allow us to appropriately share information," said Andrew Koenig, DO, medical director of Pfizer's Inflammation and Immunology Group.

"It is important for FDA to understand that its current approach has implications beyond off-label communications," read Koenig's prepared statement. "For example, in the preapproval space, the current regulatory scheme can hinder us in communicating with payers about our investigational medicines, and limit patients from getting prompt access to those medicines upon approval. Even after a medicine is approved, the current framework chills our ability to communicate very useful information relating to our approved indications."

"Open, transparent communication between manufacturers and healthcare providers is absolutely key to improve and protect public health," said Danelle Miller, of Roche Diagnostics. "We urge the agency to move quickly to bring reasonableness and clarity."

More than 30 speakers made short presentations during Wednesday's day-long hearing.

FDA Commissioner Robert Califf, MD, said one issue FDA hopes to have addressed at the hearing is "the extent to which healthcare providers face challenges."

"Transparency helps to fulfill the ethical commitment researchers owe," he said. "The medical products community has promoted unapproved products ... There have been many instances in which the use of these products has been shown to be unsafe, even when the unapproved use was (generally) accepted.

"This is a complex topic and the public health stakes are high."

Scheduled speakers Thursday include representatives of Johns Hopkins Bloomberg School of Public Health, Georgetown University Medical Center and Children's National Health System. The meeting is scheduled to conclude with 39 minutes of open public comments, capped at 3 minutes each.

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